Phase III Clinical Study of VC005 in Adult and Adolescents With Mild to Moderate Atopic Dermatitis

NCT07592585 | Not Yet Recruiting Phase 3

• 1 other identifier: VC005-303
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, randomized, double-blind, vehicle controlled phase III clinical study to evaluate the efficacy and safety of VC005 in adults and adolescents with mild to moderate atopic dermatitis

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving an Investigator's Global Assessment (IGA) response (defined as an IGA score of 0 or 1 with a reduction of ≥2 points from baseline)

  Week 8

Study Arms (2)

VC005 groups

EXPERIMENTAL

Drug: VC005

VC005 Placebo group

PLACEBO COMPARATOR

Drug: VC005 Placebo

Interventions

VC005 DRUG

VC005 Placebo group with Local topical application

VC005 groups

VC005 Placebo DRUG

VC005 Placebo group with Local topical application

VC005 Placebo group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects fully understand this study, are able to follow the relevant procedures of the trial, voluntarily participate in the clinical trial, and sign the informed consent form (ICF);
• The age requirement for signing the ICF is 12 years old or above, with no gender restrictions;
• During screening, the diagnosis of atopic dermatitis should be met according to the Hanifin-Rajka criteria.

You may not qualify if:

• Patients whose AD course is judged by the investigator as unstable(spontaneous improvement or rapid worsening) within 2 weeks prior to baseline;
• At screening and baseline, lesions are localized only to the hands or feet, with no prior history of involvement of other typical areas (such as the face or flexural areas);
• Skin damage or abnormalities that may affect the evaluation of the investigational drug administration site (e.g., pigmentation, extensive scarring, tattoos, etc., at the affected area);
• At screening and baseline, presence of skin diseases that may affect the evaluation of the administration site, including but not limited to: psoriasis, acne, skin cancer, generalized erythroderma, Netherton syndrome, etc.

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

Chinese Academy of Medical Sciences Hospital for Skin Disease

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• qianjin Lu

  Chinese Academy of Medical Sciences Hospital for Skin Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaojuan lai

CONTACT

+8615358160458; lai_xiaojuan@vcarepharmatech.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

CN (1)